Symani Surgical System

The Symani Surgical System is an electromechanical robotic-assisted device designed to assist microsurgeons in performing precise vascular anastomosis, suturing, and ligation on small blood vessels and lymphatic ducts (0.1-2.5 mm diameter) during free-flap reconstruction surgery in the breast, mouth, scalp, extremities, and lymphatic surgery. The system provides motion scaling (7x to 20x magnification) to reduce surgeon tremor and improve dexterity, intended for use by trained physicians in adults.

The Symani Surgical System has identical technological characteristics to its predicate device (DEN230032). It consists of three components: a CMM (control motion module), Console, and Instruments with wristed end-effectors. This 510(k) submission represents a labeling modification only, adding mouth and scalp indications to the existing open free-flap surgery indication; no design or technological changes were made.

Not stated in this summary.

Substantial equivalence is established because: (1) the subject device has identical intended use and technological characteristics as the predicate device; (2) clinical data from 62 patients (55 prospective, 7 retrospective) undergoing mouth and scalp free-flap procedures demonstrated safety and effectiveness comparable to the predicate, with 90.9% patency at first attempt for mouth procedures and 100% final patency for all anastomoses; and (3) zero serious adverse device effects occurred, with adverse event rates consistent with published literature for head/neck procedures. The lower scalp first-attempt patency (69.2%) is attributable to unique anatomical challenges, but final patency confirmation prior to closure mitigates this difference.